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Gut check: new study targets stomach woes in female athletes

NCT ID NCT07366931

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily postbiotic supplement (humiome® post LB) can reduce gastrointestinal symptoms like bloating and discomfort in 100 female athletes. Participants will take the supplement or a placebo for several weeks, and researchers will track symptoms during exercise and across menstrual cycle phases. The goal is to find a simple, non-drug way to help female athletes manage gut issues that often disrupt training and performance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female, cisgender, premenopausal. 2. Minimum age 18 years. 3. Regular, natural menstrual cycle (21-35 days in duration), with 9 or more consecutive periods per year, if possible documented with tracker apps, calendars, or other tools. 4. Willingness and ability to give informed consent and to understand, to participate, and to comply with the clinical study requirements. 5. Body mass index (BMI) ≥ 18.5 and \< 24.9 kg/m2 6. Agreeing to maintain lifestyle habits during the study (same dietary and physical activity habits) 7. Having a smartphone and a history of consistent tracking of training and health records via apps. 8. Having regular GI issues during exercise, preferably also during menstruation. During pre-screening, this will be assessed with a shortened GSRS questionnaire, where participants need to have had, in the month preceding pre-screening, the equivalent of at least a score of 2 in a GSRS focus area (diarrhoea, pain, indigestion). 9. No relevant self-reported abnormalities from medical history. 10. Trained athlete (trains at least 3 times per week for more than 1 hour per day and who has been involved in endurance training for at least 2 years in alignment with previous research (Pfeiffer et al., 2010). This will be evaluated by assessing training records (Strava or similar application, certificates of attendance to athletic events, club membership, etc.). 11. Access to a health-care provider, who can be contacted by the CRO, and who reside in areas with available health services. Exclusion Criteria: 1. Individuals who are pregnant, lactating, or plan to become pregnant before study end. 2. Individuals with secondary amenorrhea. 3. Individuals who use hormonal contraceptives during the last 6 months before (and during) the trial. 4. Individuals who are currently participating in another clinical trial or have participated in a trial within the last two months prior to enrolment. 5. Tobacco smokers and vapers. 6. Individuals with acute illness. 7. Individuals with a current musculoskeletal injury or one within the last month. 8. Individuals taking probiotic supplements or who have taken probiotics two weeks prior to enrolment. 9. Individuals controlling chronic diseases with treatments known to alter the intestinal microbiome or to alter GI symptoms, such as certain pain killers, antacids, proton-pump inhibitors, anti-diarrhoeal medication or supplements, and laxatives. 10. Individuals having received antibiotics treatments within three months of trial start. 11. Individuals having planned major changes in lifestyle (i.e. diet, weight loss program, exercise level, travelling) during the duration of the study. 12. Individuals who have any hypersensitivity/allergy to any of the components of the test product. 13. Individuals who have planned major elective surgery during the study period.

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As listed by the trial registrant

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How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Liverpool John Moores University

    Liverpool, United Kingdom

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